UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036393
Receipt No. R000041440
Scientific Title Nonpharmacologic intervention for Behavioral and psychological symptoms of dementia using the positive emotions of patients with Alzheimer's disease
Date of disclosure of the study information 2019/04/03
Last modified on 2019/10/03

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Nonpharmacologic intervention for Behavioral and psychological symptoms of dementia using the positive emotions of patients with Alzheimer's disease
Acronym Nonpharmacologic intervention for BPSD for patients with Alzheimer's disease
Scientific Title Nonpharmacologic intervention for Behavioral and psychological symptoms of dementia using the positive emotions of patients with Alzheimer's disease
Scientific Title:Acronym Nonpharmacologic intervention for BPSD for patients with Alzheimer's disease
Region
Japan

Condition
Condition Alzheimer's disease
Classification by specialty
Nursing
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Positive emotion is brought out from a patient with Alzheimer's disease by non-pharmacological intervention, and research into the change in BPSD, daily living behavior, language quantity and contents of language, are carry out.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of BPSD using Neuropsychiatric Inventory.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Intervention using nostalgic music and reminiscence.Four times, two months.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
70 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1. Elderly people diagnosed with Alzheimer's disease.
2. Elderly persons with Alzheimer's disease admitted to a mental hospital.
3. Conversation is possible.
4. There is no problem with vision and hearing.
Key exclusion criteria 1.Serious behavior and psychological symptoms
2.A doctor in charge judges that participation in the research is unsuitable.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Mie
Middle name
Last name Urabe
Organization Kyoto Prefectural University of Medicine
Division name School of Nursing
Zip code 602-0857
Address 410 Nakagoryo-cho, Kamigyo-ku, Kyoto, Japan
TEL 075-212-5444
Email urabem@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name Mie
Middle name
Last name Urabe
Organization Kyoto Prefectural University of Medicine
Division name School of Nursing
Zip code 602-0857
Address 410 Nakagoryo-cho, Kamigyo-ku, Kyoto, Japan
TEL 075-212-5444
Homepage URL
Email urabem@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine
Institute
Department

Funding Source
Organization Ministry of education
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyoto Prefectural University of Medicine
Address 410 Nakagoryo-cho, Kamigyo-ku, Kyoto, Japan
Tel 075-212-5444
Email urabem@koto.kpu-m.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 03 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 04 Month 02 Day
Date of IRB
2019 Year 09 Month 12 Day
Anticipated trial start date
2019 Year 04 Month 03 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 03 Day
Last modified on
2019 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041440

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.